MAUDE Adverse Event Report: MEDTRONIC STRATA VALVE; VENTRAL-PERITONEAL SHUNT

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Headache (1880); Nausea (1970); Visual Impairment (2138); No Code Available (3191)

Event Date 02/18/2015

Event Type  Injury  

Event Description

My medtronic programme ventral peritoneal valve/shunt that was implanted in (b)(6) 2014 apparently had a manufacturing defect in it.It had a hole that meant that it was not siphoning off the amount of cranial fluid that it was intended to siphon off, leading to increased cranial pressure over a six-month period.The neurosurgeon caught it after a series of ct scans and x-rays showed increased pooling of the fluid in my brain area which had been causing severe headaches, nausea and sight problems.The x-ray and ct scan showed nothing wrong with the device or catheters, so the dr had to perform surgery to review the catheters and the device.Upon review, he noticed the defect and replaced the valve.I was required to stay in the hospital for two days and recuperate at home for an additional week.

• Brand Name: STRATA VALVE
• Type of Device: VENTRAL-PERITONEAL SHUNT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4586039
• MDR Text Key: 5481019
• Report Number: MW5041363
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 6 MO
• Patient Weight: 65